CMS payment rate established for ArteraAI prostate cancer test

The Centers for Medicare & Medicaid Services (CMS) have established a payment rate for the ArteraAI prostate cancer test, a multimodal artificial intelligence (MMAI) biomarker test that can predict therapy benefit and prognosticate long-term outcomes of treatment in patients with localized prostate cancer, according to a news release from ArteraAI, the developer of the test.¹

Data on the ability of the test to predict long-term ADT benefit were presented at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.

The CMS payment rate became effective on January 1, 2024.

“This marks a noteworthy milestone in advancing personalized cancer care and underscores the pivotal role of AI in transforming cancer treatment,” said Andre Esteva, CEO and co-founder of ArteraAI, in the news release. “The ArteraAI Prostate Test is just one among several AI-enabled services that have secured payment rates, and as the industry navigates its evolving landscape, this decision serves as a promising indicator for both ArteraAI and the broader spectrum of medical AI companies.”¹

According to the company, the ArteraAI prostate cancer test uses an algorithm that includes digital images from patients’ biopsy in combination with patients’ clinical data to predict therapy benefit. The test has been validated in phase 3 randomized clinical trials.

Data on ArteraAI

A recent validation study of the AI-based model showed that the test was able to identify patients likely to benefit from short-term androgen deprivation therapy (ADT).²

In total, the study included 5727 patients in the testing cohort, who were enrolled across 5 phase 3 randomized trials in which they were treated with radiotherapy with or without ADT. The validation cohort for the study included 1594 patients from the RTOG 9408 trial, which randomly assigned men to radiotherapy plus or minus 4 months of ADT. The median follow-up for patients in the validation cohort was 14.9 years.

Overall, 543 (34%) patients in the validation cohort were AI-biomarker positive, and 1051 were AI-biomarker negative. ADT was shown to significantly reduce the risk of distant metastasis (DM) compared with radiotherapy alone. Patients who were AI-biomarker negative did not experience benefit from treatment with ADT, leading the authors to conclude validity of the test for short-term hormone therapy.

Further, data on the ability of the test to predict long-term ADT benefit were presented at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.³

In total, 2641 men from RTOG 9408, 9413, 9902, 9910, and 0521 were included in the training cohort. The model was validated using data on 1192 men from RTOG 9202 with a median follow-up of 17.2 years. The primary end point for the analysis was DM.

Overall, the data showed that the AI model was prognostic for DM (sHR, 2.35; 95% CI, 1.72-3.19;P < .001). Patients who were AI-biomarker positive (n = 785; 66%) showed reduced DM (sHR, 0.55; 95% CI, 0.41-0.73; P < .001) and reduced risk of death with DM (HR = 0.57; P = .11) with long-term ADT. Men who were AI-biomarker negative (n = 407; 34%) showed no benefit in DM (sHR, 1.06; 95% CI, 0.61-1.84; P = .84) with long-term ADT.

The investigators also compared DM outcomes among patients who received radiotherapy plus long-term ADT vs those who received radiotherapy plus short-term ADT. A 10-year difference of 13% was seen in DM among patients who were AI-biomarker positive between the 2 groups. There was a difference of 2% in DM among patients who were AI-biomarker negative.

Overall, the authors concluded that the AI model was predictive for long-term ADT benefit, having identified 34% of men who could have derived a similar benefit with short-term ADT, and 43% of intermediate-risk men who would benefit from long-term ADT.

References

1. ArteraAI receives Medicare payment rate for the ArteraAI Prostate Cancer test. News release. ArteraAI. January 3, 2024. Accessed January 4, 2024. https://www.businesswire.com/news/home/20240103190751/en/ArteraAI-Receives-Medicare-Payment-Rate-for-the-ArteraAI-Prostate-Cancer-Test

2. Spratt DE, Tang S, Sun Y, et al. Artificial intelligence predictive model for hormone therapy use in prostate cancer. NEJM Evid. 2023;2(8). doi:10.1056/EVIDoa2300023

3. Armstrong AJ, Liu VYT, Selvaraju RR, et al. Development and validation of an AI-derived digital pathology-based biomarker to predict benefit of long-term androgen deprivation therapy with radiotherapy in men with localized high-risk prostate cancer across multiple phase III NRG/RTOG trials. J Clin Oncol. 2023;16(suppl)5001: doi:10.1200/JCO.2023.41.16_suppl.5001